UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effect of rehabilitative intervention on childhood cancer during and after treatment
Acronym	Effective rehabilitation for children with cancer
Scientific Title	A study on the effect of rehabilitative intervention on childhood cancer during and after treatment
Scientific Title:Acronym	Effective rehabilitation for children with cancer
Region	Japan

Condition
Condition	childhood cencer
Classification by specialty	Pediatrics Rehabilitation medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the period of effective rehabilitation intervention for pediatric cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Six-minute walk test: before and after cancer therapy, then after one year
Key secondary outcomes	Grip strength; Knee extension strength; One leg stand test; Timed up and go test; New physical fitness test of Japanese MEXT; Wechsler intelligence scale; Functional independence measure/functional assessment measure; Pediatric quality of life inventory; body composition; biochemical data; brain imaging

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Early rehabilitation (simultaneously with the start of cancer treatment)
Interventions/Control_2	Traditional rehabilitation (start from tapering phase of cancer treatment)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	5 years-old <=
Age-upper limit	20 years-old >=
Gender	Male and Female
Key inclusion criteria	Children with cancer Cancer therapy and hospitalization
Key exclusion criteria	Severe developmental disorder Communication disorder Astasia-abasia Severe exercise-induced asthma The terminal phase of the disease
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuma Sonoda
Organization	Shiga University of Medical Science Hospital
Division name	Rehabilitation Units
Zip code
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2670
Email	yuma@belle.shiga-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yuma Sonoda
Organization	Shiga University of Medical Science Hospital
Division name	Rehabilitation Units
Zip code
Address	Seta Tsukinowa-cho, Otsu, Shiga
TEL	077-548-2670
Homepage URL
Email	yuma@belle.shiga-med.ac.jp

Sponsor
Institute	Rehabilitation Units, Shiga University of Medical Science Hospital
Institute
Department

Funding Source
Organization	Rehabilitation Units, Shiga University of Medical Science Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Pediatrics, Shiga University of Medical Science Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 29 Day
Date of IRB	2015 Year 09 Month 29 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 16 Day
Last modified on	2020 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022829